21 CFR 812 & A Principal Investigator’s Oversight”

According to the regulations for clinical trials, the PI is personally responsible for conducting and supervising the conduct of human subjects research by “protecting the rights, safety, and welfare of subject’s under the investigator’s care”. The PI also has to ensure that all the research he is responsible for is conducted in an ethical manner and in accordance with all federal, state, and local laws and regulations, institutional policies, and the requirements of the IRB. So what exactly is “oversight”? Oversight is defined in the Merriam-Webster’s online dictionary as “management by overseeing the performance or operation of a person or group; watchful care, superintendence, general supervision”. As you can imagine, this can be quite an undertaking.

In order to provide oversight and to ensure that the rights, safety, and welfare of research subjects is protected the PI must ensure that (among other things):

He/she or another qualified individual provides study subjects with reasonable medical care for any adverse events, including and clinically significant laboratory values, related to the research

He/she or another qualified individual is available to study subject to answer questions or provide care during the conduct of the research

All research staff adhere to the research plan (i.e., inclusion/exclusion criteria, safety assessments, safety monitoring and reporting of unanticipated problems)

There is protection of privacy and confidentiality of identifiable data

There is minimization of risks to the subjects

An investigator also is responsible for ensuring that informed consent is obtained in accordance with the regulations

It is the PI’s responsibility to not begin any research study without adequate resources to protect the subjects who are participating. The PI should have a plan for supervision of all tasks throughout the investigation. The FDA offers Guidance on Investigator Responsibilities for suggestions on how to take on all this responsibility. With so many regulations from various entities to abide by, it becomes clear why oversight can sometimes become “an oversight”.

So how can PI oversight make or break a clinical trial? We want to hear your experiences.